Calcium Balance Studies in Children With CKD and on Dialysis

NCT03285854 | Unknown DMC

• 1 other identifier: 15HM36
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.

Conditions

Chronic Kidney Disease Mineral and Bone Disorder

Keywords

CKD; Dialysis; calcium; mineral and bone disorder (MBD); calcification; DXA; peripheral quantitative CT scan (pqCT)

Outcome Measures

Primary Outcomes (3)

• Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD

  available on request

  24 months

• number of children with fractures, and clinical and biochemical correlates of fractures

  available on request

  12 months

• Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan

  available on request

  24 months

Study Arms (2)

Children with CKD stage 3-5 and dialysis

Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis

Diagnostic Test: Collection of blood, urine and stool samples

Healthy age and gender matched children

1. All children \<18 years 2. Normal renal function (eGFR 90-120ml/min/1.73m2 \[calculated by Schwartz formula\] in children \>1 year and serum creatinine \<35μMol/L in children \<1 year) 3. Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.

Diagnostic Test: Collection of blood, urine and stool samples

Interventions

Collection of blood, urine and stool samples DIAGNOSTIC_TEST

Collection of blood, urine and stool samples, diet diary and bone scans

Also known as: DEXA - lumbar spine and hips, tibial peripheral quantitative CT, Dietary record

Children with CKD stage 3-5 and dialysis; Healthy age and gender matched children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls

You may qualify if:

• All children \<18 years
• Normal renal function (eGFR 90-120ml/min/1.73m2 \[calculated by Schwartz formula\] in children \>1 year and serum creatinine \<35μMol/L in children \<1 year)
• Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.

You may not qualify if:

• Pre-existing bone disease - inherited or acquired
• Fractures in the preceding 6 months
• Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
• Bisphosphonate therapy at any time in the past
• Any acute illness in the preceding 2 weeks (when the child is unable to maintain their usual diet or has bed rest)
• II - For CKD and dialysis children
• Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis.
• As listed above for healthy children.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University of Kiel: collaborator
• Athens General Children's Hospital "Pan. & Aglaia Kyriakou": collaborator
• Cukurova University: collaborator

Study Sites (1)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, stool and dialysis fluid samples will be collected

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Calcinosis; Bone Diseases

Interventions

Urination

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Rukshana C Shroff, MD PhD

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 18, 2017
• Study Start: February 1, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

GB (1)